PREZISTA(R) (darunavir) Receives Expanded Marketing Authorisation in the European Union for Treatment-Experienced Adults With HIV-1

03.12.2008 – 11:06

Cork, Ireland (ots/PRNewswire) -
- For Medical Media Only
- PREZISTA now Indicated for the Broad Range of
Treatment-Experienced Patients in the 27 EU Member States
Tibotec Pharmaceuticals announced today that the European
Commission adopted the decision to broaden the indication for
PREZISTA(R) (darunavir), a protease inhibitor, in combination with
ritonavir and other antiretroviral medicinal products to the
treatment of HIV-1 infection in all treatment-experienced adult
patients. Darunavir was developed by Tibotec Pharmaceuticals, Cork,
Ireland. Tibotec, a division of Janssen-Cilag, is the organisation
responsible for marketing the brand in Europe.
"The availability of darunavir for the full spectrum of
treatment-experienced patients in the European Union (EU) provides
caregivers and patients with important additional options to manage
HIV," said Roger Pomerantz, M.D., President of Tibotec Research and
Development. "Our scientists and development teams are deservingly
proud of the difference they make in helping to address the unmet
needs of people living with HIV. We will continue our commitment to
developing innovative treatment options to help fight HIV and other
infectious diseases."
This Commission decision signifies that the treatment is
authorised for use in the European Union, valid in all 27 EU member
states. In 2007, a conditional marketing authorisation was granted to
darunavir, taken in combination with ritonavir and other
antiretroviral medicinal products. This earlier conditional approval
limited the use of darunavir to the treatment of highly pre-treated
adult patients who failed on more than one regimen containing a
protease inhibitor. The full marketing authorisation from the
European Commission is expected by the end of December 2008.
Following today's decision, darunavir, co-administered with 100
mg ritonavir is indicated in combination with other antiretroviral
medicinal products for the treatment of human immunodeficiency virus
(HIV-1) infection in treatment-experienced adult patients, including
those that have been highly pre-treated.
The extended indication was based on the 48-week analysis of the
phase 3 TITAN trial in treatment-experienced lopinavir/r-naïve
patients. Forty-eight week results from TITAN in lopinavir/r-naïve,
treatment-experienced adults:
- Seventy-seven percent of patients in the darunavir/r arm (n=298) vs. 67
percent of patients in the lopinavir/r arm (n=297) reached less than
400 copies/mL, (study demonstrated non-inferiority, p<0.0001).
Detailed conditions for the use of this product are described in
the updated Summary of Product Characteristics (SmPC), and will be
published in the revised European Public Assessment Report (EPAR)
which will be available in all official European Union languages.
Important Safety Information
In the registrational studies, darunavir was generally well
tolerated versus the investigator selected PIs. The majority of the
adverse reactions reported in patients who initiated therapy with
darunavir 600 mg co-administered with 100 mg ritonavir twice daily
were mild to moderate in severity. Thirty percent of the patients
experienced at least one adverse drug reaction (at least grade 2 in
severity and considered by the investigator at least possibly related
to darunavir co-administered with 100 mg ritonavir). The most
frequently (greater than or equal to 2 percent) of those reported
adverse reactions were diarrhoea (3.9 percent),
hypertriglyceridaemia (3.8 percent), rash (2.8 percent), nausea (2.6
percent), hypercholesterolaemia (2.5 percent) and headache (2.0
percent). 2.6 percent of the patients discontinued treatment due to
adverse reactions.
Before taking darunavir, patients should tell their doctor if
they have any medical conditions, including liver problems, including
hepatitis B or C, diabetes, symptoms of infections, change in body
fat, haemophilia, musculoskeletal problems, or allergy to sulfa
medicines and should tell their doctor if they are pregnant or
planning to become pregnant, or are nursing.
Darunavir should not be used in patients allergic
(hypersensitive) to darunavir or ritonavir or with severe liver
problems.
There are some relevant drug-drug interactions with other
medications commonly used in HIV patient populations, such as other
antiretroviral medications. Patients should talk to their healthcare
provider about all the medicines they are taking or plan to take,
including prescription and non-prescription medicines, vitamins, and
herbal supplements.
Darunavir does not cure HIV infection or AIDS, and does not
prevent passing HIV to others.
Please see full Summary of Product Characteristics or visit
http://www.emea.europa.eu for more details
About Tibotec Pharmaceuticals
Tibotec Pharmaceuticals, based in Cork, Ireland, is a
pharmaceutical research and development company, with offices in
Yardley, PA, USA and main research and development operations/labs in
Mechelen, Belgium. Tibotec is dedicated to the discovery and
development of innovative HIV/AIDS drugs and anti-infectives for
diseases of high unmet medical need.
About Tibotec, a division of Janssen-Cilag
Tibotec, a division of Janssen-Cilag, brings innovative products
for HIV/AIDS to patients in Europe, the Middle East and Africa
focusing on patients' and healthcare providers' specific needs in
this disease domain. The company will also commercialise medicines to
combat other viral diseases in the future.
About Janssen-Cilag
Janssen-Cilag is a leader in traditional and biological medicines
for disorders such as in gastroenterology, women's health, mental
health and neurology as well as for pain, oncology, haematology and
nephrology.
(This press release contains "forward-looking statements" as
defined in the Private Securities Litigation Reform Act of 1995.
These statements are based on current expectations of future events.
If underlying assumptions prove inaccurate or unknown risks or
uncertainties materialize, actual results could vary materially from
the Company's expectations and projections. Risks and uncertainties
include general industry conditions and competition; economic
conditions, such as interest rate and currency exchange rate
fluctuations; technological advances and patents attained by
competitors; challenges inherent in new product development,
including obtaining regulatory approvals; domestic and foreign health
care reforms and governmental laws and regulations; and trends toward
health care cost containment. A further list and description of these
risks, uncertainties and other factors can be found in Exhibit 99 of
Johnson & Johnson's Annual Report on Form 10-K for the fiscal year
ended December 30, 2007. Copies of this Form 10-K, as well as
subsequent filings, are available online at http://www.sec.gov,
http://www.jnj.com or on request from Johnson & Johnson. The Company
does not undertake to update any forward-looking statements as a
result of new information or future events or developments.)
Tibotec is a member of the Johnson & Johnson family of companies.
ots Originaltext: Tibotec Pharmaceuticals Ltd.
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